MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE

Lot Number 218288302

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Weakness (2145); Dizziness (2194); Joint Swelling (2356)

Event Date 11/13/2017

Event Type  Injury  

Event Description

Bilateral knee injections received on (b)(6) 2017.One hour after injections patient experienced pain, swelling, generalized weakness, light headedness, n/v, tingling in feet.Dose or amount: 6 ml millilitre(s).Frequency: other - once.Route: intra-articular.Therapy start date: (b)(6) 2017.Therapy end date: (b)(6) 2017.Diagnosis or reason for use: arthritis of knees.

• Brand Name: SYNVISC ONE
• Type of Device: SYNVISC ONE
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 7154363
• MDR Text Key: 96177207
• Report Number: MW5074280
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 218288302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 107